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Alkylating agents

Sacituzumab Govitecan Combo for Lung Cancer (EVOKE-02 Trial)

Phase 2
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator No prior systemic treatment for metastatic NSCLC
Must not have
Mixed SCLC and NSCLC histology
Active second malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial is testing a new combination therapy for advanced or metastatic non-small-cell lung cancer (NSCLC) that has not responded to other treatments. The primary objectives are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of the new therapy.

Who is the study for?
This trial is for adults with advanced or metastatic non-small-cell lung cancer (NSCLC) who haven't had systemic treatment for it. They should have a good performance status, meaning they can carry out daily activities with little or no assistance. Their blood counts and liver function need to be within certain ranges, and their disease must be measurable on scans.
What is being tested?
Researchers are testing the drug sacituzumab govitecan-hziy (SG), alone and in combination with pembrolizumab and either carboplatin or cisplatin. The study aims to find effective dosing regimens for patients with NSCLC that has spread beyond its original site.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, lowered blood cell counts which can increase infection risk, potential liver issues, fatigue, nausea, and other symptoms related to how these drugs affect the body's normal cells as well as cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at stage IV.
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My cancer can be measured on scans and I haven't had systemic treatment for advanced lung cancer.
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I am fully active or can carry out light work.
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My lung cancer is at stage IV.
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My cancer can be measured on scans according to specific criteria.
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I haven't had any systemic treatment for my advanced lung cancer.
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I am fully active or can carry out light work.
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My lung cancer is at stage IV.
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My cancer can be measured on scans.
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I haven't had any systemic treatment for my advanced lung cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung cancer is a mix of small cell and non-small cell types.
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I have another type of cancer that is currently active.
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My NSCLC can be treated with local therapy only.
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I have an immune system disorder or am on long-term steroids.
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I have been treated for an autoimmune disease in the last 2 years.
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I have received an organ or tissue transplant from another person.
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I have a severe allergy to SG, pembrolizumab, carboplatin, or cisplatin.
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I have undergone radiation therapy for my lung.
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I haven't had any cancer treatment in the last 6 months.
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I have severe lung problems due to other lung diseases.
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I have active cancer spread to my brain or spinal cord.
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I have a history of heart disease.
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I have an ongoing inflammatory bowel condition.
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I am currently taking antibiotics for a serious infection.
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I have an ongoing or chronic hepatitis B infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Secondary study objectives
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Duration of Response as Assessed by IRC per RECIST Version 1.1
Overall Survival
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

7Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)Experimental Treatment2 Interventions
Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
Group II: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)Experimental Treatment3 Interventions
Participants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m^2 on Day 1 of a 21-day cycle.
Group III: SG + Pembrolizumab + Cisplatin (Cohort E)Experimental Treatment3 Interventions
Participants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m^2 on Day 1 of a 21-day cycle.
Group IV: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)Experimental Treatment4 Interventions
Participants assigned to Cohort D according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
Group V: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)Experimental Treatment4 Interventions
Participants assigned to Cohort C according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
Group VI: SG + Pembrolizumab + Carboplatin Safety Run-inExperimental Treatment3 Interventions
Participants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle.
Group VII: SG + Pembrolizumab (Cohort B)Experimental Treatment2 Interventions
Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy (SG)
2012
Completed Phase 2
~520
Pembrolizumab
2017
Completed Phase 2
~2070
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~2360

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,098 Previous Clinical Trials
860,245 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,759 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
351 Previous Clinical Trials
189,136 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05186974 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: SG + Pembrolizumab + Carboplatin Safety Run-in, SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C), SG + Pembrolizumab + Cisplatin (Cohort E), SG + Pembrolizumab + Cisplatin Safety Run-in (Optional), SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D), Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A), SG + Pembrolizumab (Cohort B)
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05186974 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05186974 — Phase 2
~69 spots leftby Sep 2025
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